Catalog Number

34-2264-51

Brand Name

ImmunoCAP IgE/ECP/Tryptase Sample Diluent

Version/Model Number

34-2264-51

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K133404,K133404

Product Code

DGC

Product Code Name

IGE, ANTIGEN, ANTISERUM, CONTROL

Public Device Record Key

a25612c2-fb27-442d-8d3a-502565c358fc

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

07333066000022

Quantity per Package

6

Contains DI Package

07333066011356

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-